10,000 results
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87ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PHILIPS RESPIRONICS DREAMSTATION
FDA Adverse Event
Injury
·PHILIPS / RESPIRONICS, INC.·Product code BZD·February 22, 2022
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 22, 2021
COVID 19 HOME TEST
FDA Adverse Event
Malfunction
·ELLUME LIMITED·Product code QKP·January 24, 2022
COBAS 8000 E 801 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·June 9, 2022
COBAS PRO ISE ANALYTICAL UNIT
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·July 15, 2024
PRIMEADVANCED
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LGW·April 17, 2012
CENTRAL LINE
FDA Adverse Event
Injury
·Product code FOZ·October 8, 2021
AXSYM CORE REAGENT
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code LOM·January 27, 2009
SIMPLEXA COVID-19 DIRECT ASSAY
FDA Adverse Event
Malfunction
·DIASORIN MOLECULAR LLC·Product code QJR·May 25, 2021
VIDAS SARS-COV-2 IGM
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code QKO·June 24, 2021
SIMPLEXA COVID-19 DIRECT ASSAY
FDA Adverse Event
Malfunction
·DIASORIN MOLECULAR LLC·Product code QJR·November 10, 2021
ORTHO VISION ANALYZER
FDA Adverse Event
Malfunction
·ORTHO CLINICAL DIAGNOSTICS·Product code KSZ·June 3, 2021
ALINITY C PROCESSING MODULE
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code JJE·April 9, 2021
ARCHITECT C4000
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code JJE·July 23, 2024
ARCHITECT C16000
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code JJE·July 10, 2024
ALINITY C PROCESSING MODULE
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code JJE·December 24, 2025
ALINITY C PROCESSING MODULE
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code JJE·December 17, 2025
ARCHITECT C4000 PROCESSING MODULE (INTEGRATED)
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code JJE·December 22, 2025
APTIMA HIV-1 QUANT DX ASSAY
FDA Adverse Event
Injury
·HOLOGIC, INC.·Product code MZF·December 2, 2025
SARS-COV-2 IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code QKO·September 10, 2020